August 2019 | Andaman Medical

Introducing New Online Courses in Medical Device Registration with Andaman Medical

Our online e-Learning platform is designed to be flexible and intuitive, breaking down the complicated details of medical device registration and regulatory affairs requirements into a format that is easy to understand and use, allowing you to meet your goals with less time and effort

Navigating the complexities of the diverse medical device/IVD registration and regulatory affairs processes in South East Asia can be challenging. That’s why Andaman Medical has launched a new e-Learning platform offering specialized training to supplement your existing quality affairs and regulatory knowledge. Our online e-Learning platform is designed to be flexible and intuitive, breaking down the complicated details of medical device regulatory and quality affairs requirements into a format that is easy to understand and use, allowing you to meet your goals with less time and effort. By the end of each course you will gain a thorough understanding of the steps of the registration process, how medical device dossiers are compiled and submitted according to regulations, as well as the details of tasks, timelines and costs associated with the process.

This platform is designed to benefit anyone involved in the regulation of medical devices; those in regulatory affairs, local authorized representatives, medical device manufacturers and distributors, healthcare professionals, medical device practitioners, and investors in the medical device sector. An example of one of the courses available is “Understanding the Medical Device Regulatory Pathway in Vietnam”. A course can be completed in as little as one hour of your time, after which your knowledge of the content can be solidified with quizzes. At the end of the course you will be awarded a certificate of completion, which will also show any continuing professional development points you may have earned. To access our e-Learning platform visit https://www.andamanmedtraining.com. Here, you will find the courses listed together with learning objectives so that you can decide whether a course is right for you. Once you find your course, you will be guided through registration to create an account online and begin your course right away. Contact our staff if you would like to find out more about our regulatory and quality affairs training services.

Andaman Medical 2019-09-01T14:09:30+08:00 August 30th, 2019|Event, Insight, News & Events|

Regulatory Affairs Professionals Society (RAPS) 2019 – Meet Andaman Medical at Booth #533

This year’s Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence 2019 will be held in Philadelphia, Pennsylvania from 21st September until 24th September 2019. Do not miss this opportunity to speak to Andaman Medical representatives at Booth #533!

It is that time of the year again – we are thrilled to catch up with familiar faces and connect with new people at the RAPS Regulatory Convergence 2019. This event has helped the regulatory community to exchange information, expand networks, resolve regulatory challenges and more.

RAPS 2019 will be held in Philadelphia, Pennsylvania from 21st September until 24th September 2019. Do not miss this opportunity to speak to Andaman Medical representatives at Booth #533. We will be able to provide you with insights into regulatory strategy particularly in ASEAN countries such as Singapore, Malaysia, Indonesia, Thailand, the Philippines and Vietnam. This is the opportunity for all of us to network with the best regulatory professionals and get the most up-to-date industry knowledge.

For more information on RAPS 2019, visit their website HERE.

Andaman Medical 2019-09-01T12:56:58+08:00 August 30th, 2019|Event, Insight, News & Events|

The Philippines: FDA Aims to Implement the AO 2018-002: Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements in October 2019

At the recent ASEAN Medical Device Committee (AMDC) meeting in Manila, the FDA’s Center for Device Regulation, Radiation Health and Research (CDRRHR) Division Chief announced that Phase 0 of AO 2018-002 implementation will cover all registrable products in circular no. 2014-005, notification of class A medical devices and medical device listing.

The FDA’s CDRRHR Division Chief, Engr. Ma. Cecilia C. Matienzo, announced during the last AMDC meeting that they aim to implement the AO 2018-002 in October 2019. This will initially cover Phase 0, which includes the following:

All registrable products listed in the FDA Memorandum Circular No 2014-005: Updated List of Medical Devices required to be registered prior to sale, distribution and use, as well as its amendments
Notification of all class A medical devices
Medical device listing.

A checklist of requirements for the notification of Class A devices & medical device listing is provided below. For all registrable products listed in FDA Memorandum Circular 2014-005 and its amendment, the checklist of requirements shall follow the ASEAN Common Submission Dossier Template in accordance with the product’s risk classification (Class B, C, or D).

Annex A: Legal Requirements for the Application of a Certificate of Notification of Medical Devices under Class A and Registration of Medical Devices under Class B, C and D

1. Notarized Application Form
2. Payment
3. Copy of Letter of Authorization. For imported medical devices, the copy of the Letter of Authorization shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the authorization is true and correct.
4. A government-issued certificate attesting to the status of the manufacturer with regards to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485. For imported medical devices, the copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
5. For imported medical devices, the Certificate of Product Notification, Certificate of Product Registration, or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency or accredited notified body in the country of origin. The copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
6. Colored picture of the device from all sides. However, the CDRRHR can require a representative sample or commercial presentation for verification purposes.

Annex B: Technical Requirements for Application of Notification of Medical Devices under Class A
1. Device description consisting of the following:
a. Intended use
b. Instructions for use
c. List of all raw materials
d. Technical specification of the finished product
e. List of reference codes, sizes, colors, models and variance; whichever is applicable
2. Certificate of Conformity (issued by government agency dealing with metrology) on the aspect of manufacture relating to metrology for devices with measuring functions, if applicable
3. Declaration of Conformity (self declaration by the manufacturer) with product standards, if applicable
4. Clear and complete colored pictures of label from all sides of the packaging (loose label or illustrations of all layers of packaging)
5. Declaration of shelf life

Annex G: Requirements for the Application of Certificate of Medical Device Listing
1. Notarized Application Form
2. Notarized letter addressed to Director, Center for Device Regulation, Radiation Health, and Research, stating that the medical device will be used solely for research, analysis, or is being donated by a certain organization and is not intended for sale. The letter should contain the following information:
a. Complete list of the devices indicating the quantity, brand and the name of the manufacturer of the product
b. Declaration that the organization shall be the sole entity responsible for the medical devices and that the CDRRHR-FDA, Department of Health will not be held liable for any safety issue concerning the product
3. Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency in the country where the device will come from
4. For a donated medical device (brand new), a certified true copy of the deed of donation, the deed of acceptance, and the packing list or any document that will show the quantity of the product
5. Copy of SEC or DTI registration, when applicable

Moreover, it was also announced that the transition period will be 2 years and in this time it is expected that the FDA will issue further announcements and memorandum circulars in relation to applicable fees, validity of certificates, and product risk classification guidelines.

Andaman Medical 2019-09-01T13:40:24+08:00 August 28th, 2019|Event, Insight, Medical Regulation Updates, News & Events|

Thailand: Medical Device Risk Classification Tool and New Notifications from the Thai Food and Drug Administration (FDA)

The Thai FDA has made a classification tool available for the public to assess medical devices in accordance with the ASEAN Agreement on Medical Device Directives (AMDD). In addition, teeth whitening products and contact lens care products were recently announced to be regulated as medical devices in Thailand.

Currently, medical devices are classified according to the level of risk that may cause harm or impact on public health. The Thai FDA, under the Thai Ministry of Public Health (MOPH), regulates medical devices in Thailand. Medical devices are categorized into one of three classes: Class I (Licensed Medical Devices, highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).

Since Thailand has aligned with the ASEAN AMDD, the medical device risk classification will adhere to guidelines on risk classifications as outlined by the AMDD. Applicants can use this tool to identify the risk classification of a medical device and must select between in vitro diagnostic products and non-in vitro diagnostic products. Sometimes the medical device may overlap as a cosmetic or drug. Therefore, if there’s a new innovation, or the applicant wishes to ensure that a product can be classified as a medical device in Thailand, the applicant may request the Thai FDA to assess the product classification and risk classification. The applicant can access the Medical Devices Risk Classification Tool via the website here. However, the English version is not available on the website and the medical device risk classification is not final, and is available on the website awaiting feedback from importers and manufacturers.

Teeth whitening products are now regulated as medical devices in Thailand
The Notification of the Ministry of Public Health (No. 135) B.E. 2561 (2019) states that teeth whitening products with hydrogen peroxide concentrations higher than 6%, or carbamide peroxide or other agents with hydrogen peroxide present or released to 6% will be classified as Notified Medical Devices (moderate risk class medical devices). This announcement came into effect on 24 March 2019. Therefore, if an importer wishes to import dental whitening products into Thailand, they must identify whether the product is considered a cosmetic or medical device. Importers with the licence to import medical equipment including teeth whitening products can submit an application for notification to the Thai FDA. Sellers of teeth whitening products must submit an application for a license to sell medical devices, and are restricted to selling these products only to hospitals which are approved for dental practice under dental professional laws or to those licensed to sell medical devices.

Contact lens care products are now also classified as a medical device in Thailand
Coming into effect on the 26 October 2019, classifications for contact lens products have changed as specified in the Notification of the Ministry of Public Health (No. 136) B.E. 2562 (2019). Importers and manufacturers of contact lens care products need toregister this product with the Thai FDA as Notification Medical Devices. These products must also include labels and instructions for use in Thai as described by the Thai FDA.

Reference: Thai FDA Website

Andaman Medical 2019-09-01T13:29:10+08:00 August 28th, 2019|Insight, Medical Regulation Updates, News & Events|

Vietnam: Exemptions in Product Registration

There are several exempted requirements for product registration in Vietnam in accordance with circular 46/2017/TT-BYT. For instance, there are a number of imported devices that do not require clinical trial reports, as well as medical devices that can be traded as normal goods without the need for a Declaration of Eligibility to Trade

In addition to the decree 36/2016/ ND-CP and the newest decree 169/2018/ND-CP about medical device management, there are some circulars that relate to the full process of medical device registration in Vietnam.

For example, the circular 46/2017/TT-BYT includes the list of imported medical devices for which clinical trial datasheets and clinical trial results are not required when applying for registration.

Here is the list of medical device which do not require clinical trials/reports for registration:
1. Peritoneal dialysis catheter
2. Catheter
3. Catheter Kit
4. Cannulae
5. Guidewire
6. Introducer

In addition, it also provides a list of class B, C, and D medical devices that may be traded as normal goods without the submission of a Declaration of Eligibility to Trade.
1. Type B home-use in vitro diagnostic devices
2. Personal blood pressure monitors
3. Electronic thermometers, infrared thermometers
4. Personal blood glucose monitoring devices: blood glucose monitors, lancing devices, test strips, lancets, control solutions
5. Nebulizers
6. Adhesive bandages
7. Artificial tears classified as medical equipment
8. Condoms
9. Vaginal contraceptive films (drug-free)
10. Vaginal lubricants
11. Electric heat bags

As circulars or decrees are updated often, the registrant will need to keep up to date on any new notifications to understand current product registration protocols. This will allow the process to work smoothly and to obtain approval on time.

Each notification from the Circular or Decree should be updated any time. Upon the evaluation/combination, the registrant will right view for completely product registration. This will help the process will work smoothly and approval on time.

Andaman Medical 2019-09-01T13:30:55+08:00 August 28th, 2019|Insight, Medical Regulation Updates, News & Events|

Monthly Archives: August 2019

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